Ultrasound Guided Local Anesthetic Field Block (A Five Step Procedure) for Open Inguinal Hernia Repair
NCT ID: NCT03193723
Last Updated: 2018-10-04
Study Results
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Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2016-10-01
2018-08-01
Brief Summary
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Detailed Description
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General anesthesia carries risks of possible airway complications, postoperative deterioration of cognitive function, sore throat, nausea, vomiting and prolonged period of immobilization with associated risk of deep vein thrombosis and longer hospital stay. Spinal anesthesia, although effective, is not without risk in patients with decompensated heart disease, recent head injury, convulsions and coagulopathies. Also spinal and epidural anesthesia have been associated with hemodynamic instability, vomiting, urinary retention, post-dural puncture headache, and backache.
Use of pre-incision infiltration of local anesthetics for field blocks has been found to be an effective adjunct as well as an alternative to spinal and general anesthesia in many studies. Combined with sedation or on its own, it offers less cardiovascular instability, early ambulation and effective post-operative pain control. Also, it has been found to reduce hospital costs by 50% and gives better patient satisfaction.
Harvey Cushing and William Halsted first described the inguinal field block in 1900. since then, its efficacy and advantages have been compared by many surgeons and anesthesiologists in a number of studies. Refinements and modifications in the technique still continue. In 1963, Joseph L Ponka described in great detail a seven step procedure of performing it in 837 patients successfully.
In 1994, Parvis and colleagues did a step by step technique for local anesthetic infiltration field block for open inguinal hernia repair.
Ultrasonography is a safe and effective form of imaging. Over the past two decades, ultrasound equipment has become more compact, of higher quality and less expensive. Ultrasounds have been used to guide needle insertion and a number of approaches to nerves and plexuses have been reported. A clear advantage of the technique is that ultrasound produces "living pictures" or "real-time" images. The identification of neuronal and adjacent anatomical structures (blood vessels, peritoneum, bone, organs) along with the needle is another advantage. Moreover, anatomical variability may be responsible for block failures, and ultrasound technology enabling direct visualization may overcome this problem. Sonographic visualization allows for the performance of extra-epineurial needle tip positioning and administration of local anesthetic avoiding intra-epineurial injection.
A modification to the technique performed by Parvis and colleagues will be tested in this study. Our modification will be performing the technique under ultrasound guidance and completely before skin incision, which, to the best of our knowledge, was not attempted in the literature before.
Local anesthesia administered before skin incision produces longer postoperative analgesia because local infiltration theoretically inhibits the build-up of local nociceptive molecules and, therefore, there is better pain control in the postoperative period.This study aims at evaluating success, efficacy, feasibility and safety of a simple five step ultrasound guided local anesthetic infiltration technique for unilateral open inguinal hernia repair and also to compare intraoperative and postoperative complications and pain control of the block with spinal anesthesia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
US guided five step field block will be performed
US guided five step field block
Ultrasound will guide needle insertion in the following layers (except intradermic injection):
* Subdermic infiltration. Approximately 8 milliliters
* Intradermic injection (making of the skin wheal). of approximately 6 milliliters.
* Deep subcutaneous injection. 8 milliliters of the mixture will be injected deep into the subcutaneous adipose
* Subfascial infiltration. Approximately eight milliliters of the anesthetic mixture will be injected immediately underneath the aponeurosis of the external oblique.
* Pubic tubercle and hernia sac injection. Occasionally, infiltration of ten milliliters of the mixture at the level of the pubic tubercle, around the neck and inside the indirect hernia sac
Group B
Spinal anesthesia will be administered in sitting position
Spinal anesthesia
Spinal anesthesia will be administered in sitting position, with 25 gauge Quincke spinal needle in L3-L4 intervertebral space, under all aseptic precautions and local infiltration, with 3.0 ml of 0.5% bupivacaine (heavy) after ensuring free, clear and adequate flow of cerebrospinal fluid. After giving spinal anesthesia, patient will be made to lie supine.
Interventions
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US guided five step field block
Ultrasound will guide needle insertion in the following layers (except intradermic injection):
* Subdermic infiltration. Approximately 8 milliliters
* Intradermic injection (making of the skin wheal). of approximately 6 milliliters.
* Deep subcutaneous injection. 8 milliliters of the mixture will be injected deep into the subcutaneous adipose
* Subfascial infiltration. Approximately eight milliliters of the anesthetic mixture will be injected immediately underneath the aponeurosis of the external oblique.
* Pubic tubercle and hernia sac injection. Occasionally, infiltration of ten milliliters of the mixture at the level of the pubic tubercle, around the neck and inside the indirect hernia sac
Spinal anesthesia
Spinal anesthesia will be administered in sitting position, with 25 gauge Quincke spinal needle in L3-L4 intervertebral space, under all aseptic precautions and local infiltration, with 3.0 ml of 0.5% bupivacaine (heavy) after ensuring free, clear and adequate flow of cerebrospinal fluid. After giving spinal anesthesia, patient will be made to lie supine.
Eligibility Criteria
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Inclusion Criteria
* Patients with unilateral inguinal hernia for elective open mesh repair hernioplasty operation.
Exclusion Criteria
* Emergency operations or operation that lasts more than two hours.
* Patients with drug or alcohol abuse history.
* Chronic pain, with daily use of analgesics.
* Contraindication to local anesthesia.
* Contraindication of spinal anesthesia.
18 Years
65 Years
ALL
No
Sponsors
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Eslam Ayman Mohamed Shawki
OTHER
Responsible Party
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Eslam Ayman Mohamed Shawki
Lecturer of anesthesia, SICU & Pain Management
Locations
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Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
Cairo, , Egypt
Countries
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References
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Anand A, Sinha PA, Kittappa K, Mulchandani MH, Debrah S, Brookstein R. Review of Inguinal Hernia Repairs by Various Surgical Techniques in a District General Hospital in the UK. Indian J Surg. 2011 Jan;73(1):13-8. doi: 10.1007/s12262-010-0156-7. Epub 2011 Jan 8.
Santos Gde C, Braga GM, Queiroz FL, Navarro TP, Gomez RS. Assessment of postoperative pain and hospital discharge after inguinal and iliohypogastric nerve block for inguinal hernia repair under spinal anesthesia: a prospective study. Rev Assoc Med Bras (1992). 2011 Sep-Oct;57(5):545-9. doi: 10.1590/s0104-42302011000500013. English, Portuguese.
Flanagan L Jr, Bascom JU. Repair of the groin hernia. Outpatient approach with local anesthesia. Surg Clin North Am. 1984 Apr;64(2):257-67. doi: 10.1016/s0039-6109(16)43283-4.
Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.
Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
Chanthong P, Abrishami A, Wong J, Herrera F, Chung F. Systematic review of questionnaires measuring patient satisfaction in ambulatory anesthesia. Anesthesiology. 2009 May;110(5):1061-7. doi: 10.1097/ALN.0b013e31819db079.
Prakash D, Heskin L, Doherty S, Galvin R. Local anaesthesia versus spinal anaesthesia in inguinal hernia repair: A systematic review and meta-analysis. Surgeon. 2017 Feb;15(1):47-57. doi: 10.1016/j.surge.2016.01.001. Epub 2016 Feb 16.
Other Identifiers
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UsHernia
Identifier Type: -
Identifier Source: org_study_id
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